First VivaGel BV launch globally in Australia by Aspen
Apr 16th, 2019
Starpharma today announced that VivaGel® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.
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Starpharma meets with US FDA to discuss VivaGel® BV
Apr 11th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel.
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Starpharma Investor Presentation to Goldman Sachs Conference
Apr 3rd, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies Conference in Sydney.
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Shareholder Update March 2019
Mar 18th, 2019
In this issue:
>> Fleurstat BVgel - Australian launch
>> Mundipharma's European launch of VivaGel® BV
>> Mundipharma's international roll-out of VivaGel® BV
>> FDA meeting to discuss VivaGel® BV approval in the US
Download: Shareholder Update March 2019 (pdf file, 453kb)
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Starpharma receives $4.0M R&D tax incentive refund
Mar 12th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a $4.0M R&D tax incentive refund which relates to the costs of research and development during the 2018 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including VivaGel® and DEP® programs. This amount was not included in Starpharma’s cash balance reported in the Company’s Interim Report for the half-year ended 31 December 2018.
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Starpharma Interim Report and Half-Year Financial Results
Feb 27th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2018.
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Quarterly Cashflow Report
Jan 30th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2018
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Shareholder Update January 2019
Jan 17th, 2019
In this issue:
>> FDA requests further data for VivaGel® BV approval in the US
>> Launch of VivaGel® BV in multiple territories
>> VivaGel® BV licensed to ITF Pharma in the US
>> VivaGel® condom approved in Japan
>> Clinical trials for internal DEP® products progressing well
>> Patent published for AstraZeneca-DEP® drugs: DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination
>> DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane®
>> SPL7013 eye drops for viral conjunctivitis
>> Partnering activities
>> Macquarie initiates coverage of Starpharma
>> Outlook
Download: Shareholder Update January 2019 (pdf file, 557kb)
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VivaGel® condom receives final regulatory approval in Japan
Jan 2nd, 2019
Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom.
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US FDA requests further data for VivaGel® BV approval
Dec 27th, 2018
Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).
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US VivaGel® BV licensed for A$142M milestones, plus royalties
Dec 20th, 2018
Melbourne, Australia: Starpharma and ITF Pharma today announced they have signed a licence for the sales and marketing rights to VivaGel® BV in the United States. Starpharma will be eligible to receive up to US$101M (A$142M) in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.
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US patent granted for SPL7013 eye drops for conjunctivitis
Dec 12th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US Patent and Trademark Office has granted a patent for SPL7013 ophthalmic drops for viral conjunctivitis. The patent has been granted with broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent term is to 2033.
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AGM - Chairman address and CEO presentation
Nov 29th, 2018
Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 3.00pm today.
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DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model
Nov 16th, 2018
Melbourne, Australia: Starpharma today announced that its proprietary DEP® docetaxel and DEP® cabazitaxel products, which are both currently in the clinic, showed significant efficacy and safety benefits over gemcitabine (Gemzar®) alone, Abraxane® (Nab-paclitaxel) alone and in combination, in a human pancreatic cancer model. These impressive efficacy results were despite the fact that these standard pancreatic cancer treatments, gemcitabine and/or Abraxane® showed limited activity in this model.
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Quarterly Cashflow Report
Oct 26th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018
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Starpharma Investor Presentation for Citi Conference
Oct 17th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) will today participate in Citi's 10th Annual Australian and New Zealand Investment Conference in Sydney.
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DEP® irinotecan outperforms in pancreatic cancer model
Sep 5th, 2018
Melbourne, Australia: Starpharma today announced that its proprietary DEP® irinotecan development candidate showed significant efficacy and safety benefits over standard irinotecan in combination with 5-FU in a mouse xenograft model of human pancreatic cancer (Figure 1 and 2). The human pancreatic tumour model used in this study virtually did not respond to the traditional irinotecan regimen (irinotecan + 5-FU), whereas complete tumour regression and 100% survival was achieved using Starpharma’s DEP® irinotecan.
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AstraZeneca’s DEP Bcl2/xL inhibitors show compelling efficacy and synergy in combination
Aug 31st, 2018
Melbourne, Australia; Starpharma today announced AstraZeneca’s first patent application on DEP® Bcl2/xL conjugates has been published by the World Intellectual Property Organisation. These DEP® Bcl2/xL conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitor for treating various cancers, including leukemias.
The published patent application shows compelling efficacy data on DEP® Bcl2/xL conjugates, both alone and in combination with other leading current anti-cancer treatments, in various preclinical human tumour models.
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Annual report and full year financial results
Aug 21st, 2018
Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2018.
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Quarterly Cashflow Report
Jul 17th, 2018
Melbourne, Australia; Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2018.
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VivaGel® BV NDA advances to next stage of FDA review
Jul 9th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US FDA has completed its filing review of the VivaGel® BV New Drug Application (NDA), with no issues identified, and confirmed its progress to the next stage.
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Starpharma licenses VivaGel® BV to Mundipharma for Europe
Jun 27th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a licence agreement for the sales and marketing rights to VivaGel®BV for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America. This deal builds on the VivaGel® BV licence signed with Mundipharma in May 2018 for Asia, the Middle East, Africa and parts of Latin America.
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Mundipharma licenses Starpharma’s VivaGel® BV
May 3rd, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a multi-region licence for the sales and marketing rights to VivaGel® BV in Asia (including China, Japan and Korea), the Middle East, Africa and the majority of Latin America.
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Quarterly Cashflow Report
Apr 30th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2018.
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Starpharma completes US New Drug Application for VivaGel® BV
Apr 30th, 2018
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its rolling new drug application (NDA) for VivaGel® BV including two indications, for the treatment of bacterial vaginosis (BV) and prevention of BV, has been completed, and the final module of the NDA will be submitted to the US Food and Drug Administration (FDA) on Monday 30 April 2018 (US time).
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Starpharma to present at OTCQX Virtual Investor Conference
Apr 11th, 2018
Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that as part of its OTCQX investor communications, a pre-recorded presentation by Chief Executive Officer Dr Jackie Fairley will be broadcast at VirtualInvestorConferences.com on Thursday 12 April 2018 at 10:30am (US ET time).
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Starpharma on CommSec’s The Executive Series
Mar 14th, 2018
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Starpharma CEO Dr Jackie Fairley speaks with CommSec’s Tom Piotrowski about the Company’s performance since March 2017, its partnership with AstraZeneca and upcoming milestones. To view the video, click here |
Starpharma CEO Dr Jackie Fairley on Channel 9’s The Today Show for International Women’s Day
Mar 8th, 2018
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As part of International Women’s Day, Starpharma CEO Dr Jackie Fairley appeared with the Federal Minister for Women Kelly O’Dwyer and Today Show presenter Georgie Gardiner to discuss women in the workforce and gender equality. To view the video, click here. |
Starpharma Interim Report and Half-Year Financial Results
Feb 26th, 2018
Starpharma today released its interim report and financial results for the half-year ended 31 December 2017.
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Starpharma receives $3.7M R&D tax incentive refund
Feb 22nd, 2018
Starpharma today announced that it has received a $3.7M R&D tax incentive refund associated with FY17 expenditures. The refund relates to eligible R&D expenditure across Starpharma’s portfolio, including VivaGel® and DEP® programs.
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Shareholder Update February 2018
Feb 19th, 2018
In this issue:
>> New sites open for the DEP® docetaxel phase 2 trial
>> DEP® cabazitaxel phase 1 / 2 trial commences
>> VivaGel® BV NDA submission lodged under Fast Track program
>> VivaGel® BV approved by TGA
>> DEP® irinotecan progressing towards the clinic
>> AstraZeneca-Starpharma collaboration
>> Extensive global licensing negotiations for VivaGel® BV
>> Positive market research findings for VivaGel® BV
>> Q2 Cashflow Report at 31 December 2017
>> OTCQX market recognition
>> Starpharma News & Events
>> Outlook
Download: Shareholder Update February 2018 (pdf file, 1.5mb)
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Starpharma to commence DEP® cabazitaxel phase 1/2 trial
Jan 31st, 2018
Starpharma today announced that it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP® cabazitaxel. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® cabazitaxel, to define a recommended phase 2 dose (RP2D), and then to determine anti-tumour efficacy of the product in select tumour types.
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VivaGel® BV treatment clinical submission under rolling submission
Dec 21st, 2017
Melbourne, Australia; 21 December 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has completed the VivaGel® BV treatment clinical section of the NDA clinical module, which will be submitted to the FDA under Starpharma’s rolling submission on Friday 22 December 2017 (US time).
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NDA submission for Starpharma’s VivaGel® BV
Nov 21st, 2017
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BioSpectrum Asia reported on Starpharma’s NDA submission for VivaGel® BV, noting that Starpharma is one of the few Australian companies to take a locally developed product to this stage. |
Starpharma receives TGA marketing approval for VivaGel® BV
Oct 25th, 2017
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Online financial news portal Finance News Network reported Starpharma received TGA marketing approval for VivaGel® BV, which is expected to be available in pharmacies in the new year under the Fleurstat™ brand. |
VivaGel® BV granted marketing approval in Australia
Oct 25th, 2017
Starpharma today announced it has received Australian marketing approval from the Therapeutic Goods Administration (TGA) for VivaGel® BV, which is intended for treatment of bacterial vaginosis (BV).
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Morgans Under the Microscope Interview featuring Dr Jackie Fairley
Oct 23rd, 2017
Morgans Under the Microscope series featured Starpharma's CEO, Dr Jackie Fairley, discussing a number of key milestones that are approaching and the licensing arrangements entered into with AstraZeneca.
Listen to the podcast (external link).
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Shareholder Update October 2017
Oct 18th, 2017
In this issue:
>> DEP® docetaxel achieves positive phase 1 results and commences phase 2
>> AZ presents first DEP® candidate AZD0466 – a Bcl2/xL inhibitor
>> Successful VivaGel® BV phase 3 results
>> Update on other internal DEP® candidates
>> Grant awarded to Starpharma-Monash
>> Starpharma and Peter Mac Cancer Centre awarded grant
>> FY17 Financial results; >$60M cash at 30 June
>> Annual Report and Annual General Meeting
>> Starpharma News & Events
Download: Shareholder Update October 2017 (pdf file, 1.3mb)
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Starpharma and Peter Mac Cancer Centre awarded DEP® Grant
Oct 9th, 2017
Starpharma and Peter MacCallum Cancer Centre have been awarded a further Federal Government Innovation Connections grant to support innovative research within Starpharma’s DEP® oncology program
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AstraZeneca presents first DEP® candidate as Bcl2/xL inhibitor
Sep 28th, 2017
Starpharma advises that AstraZeneca has this week presented its first DEP® candidate utilising Starpharma’s DEP® delivery platform, AZD0466, at the 3rd AstraZeneca-MedImmune-CRUK Cambridge Centre Symposium 2017 in Cambridge, UK.
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DEP® docetaxel positive phase 1 results; phase 2 commences
Sep 22nd, 2017
Starpharma today announced that its phase 1 trial for DEP® docetaxel has achieved the key objective of determining a Recommended Phase 2 Dose (RP2D), with no reports of protocol-defined dose limiting toxicities (DLTs). The trial has now been adapted to transition seamlessly into phase 2, with ethics and regulatory approvals already granted, and recruitment and patient screening activities underway for this next phase.
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Starpharma annual report and full year financial results
Aug 28th, 2017
Melbourne, Australia; 28 August 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2017.
Starpharma and Monash awarded STEM+ Business Fellowships
Aug 9th, 2017
Starpharma today announced that Starpharma and Monash Institute of Pharmaceutical Sciences (MIPS) have been awarded $300,000 in grant funding from the SIEF STEM+ Business Fellowship Program to engage two post-doctoral Research Fellows.
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Successful VivaGel® Phase 3 results and NDA planned for rBV
Aug 7th, 2017
Starpharma today announced that its two phase 3 trials of VivaGel® BV for prevention of recurrent bacterial vaginosis (rBV) achieved their primary objective demonstrating statistically significant superiority compared to placebo in preventing rBV based on topline data.
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Shareholder Update July 2017
Jul 4th, 2017
In this issue:
>> Starpharma sells Agrochemicals business to Agrium for $35M cash
>> DEP® irinotecan outperforms irinotecan in multiple cancer models
>> DEP® docetaxel, DEP® cabazitaxel and scale-up facilities
>> AstraZeneca pays US$2M DEP® milestone to Starpharma
>> VivaGel® BV phase 3 results timing and commercialisation
>> VivaGel® condom launched in Canada
>> Sale of Ansell's Sexual Wellness division
>> Starpharma News & Events
Download: Shareholder Update July 2017 (pdf file, 710kb)
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Sale of Agrochemicals Business Investor Presentation
Jun 14th, 2017
Melbourne, Australia; 14 June 2017: Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), will be holding an investor conference call today at 11am (AEST) to discuss the sale of its Agrochemicals business to Agrium Inc., for $35 million. A presentation featuring further information on the transaction is available.
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Starpharma sells Agrochemicals business to Agrium for $35M
Jun 14th, 2017
Melbourne, Australia; 14 June 2017: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced that it has completed a transaction to sell its agrochemicals and Priostar® business (Starpharma Agrochemicals) to Agrium, Inc., (Agrium) (NYSE: AGU, TSE: AGU) for A$35 million in cash consideration. The Starpharma Agrochemical business willl be operated by Agrium’s wholly-owned subsidiary, Loveland Products, Inc.
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DEP® irinotecan outperforms irinotecan in multiple cancer models
Jun 6th, 2017
Melbourne, Australia; Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its proprietary DEP® irinotecan has demonstrated significantly better anti‑tumour activity and increased survival compared with irinotecan in a variety of human colon cancer models.
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AstraZeneca DEP® candidate advance triggers milestone to Starpharma
Apr 20th, 2017
Starpharma announced the achievement of a key preclinical milestone for its DEP® drug delivery technology in combination with a proprietary oncology molecule from AstraZeneca.
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Ansell launches VivaGel® condom in Canada
Apr 12th, 2017
Starpharma is pleased to announce the VivaGel® condom has been launched in Canada by Ansell under the LifeStyles® Dual Protect™ brand.
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